A Comparison of Post-Sternotomy Dressings

N/ACompletedNCT02198066

Carilion Clinic351 enrolled

Overview

The purpose of this study was to determine which of three types of dressings, a dry sterile dressing, a metallic silver dressing or an ionic silver dressing provided better patient outcomes for the post-sternotomy cardiac surgery patient population. In this prospective, randomized controlled trial, the hypothesis was that subjects who received either of the silver impregnated dressings would have better outcomes (better wound healing, less discomfort, and less incidence of infection). Investigators also evaluated dressing factors such as adherence, time for application and ease of use.

No other information included.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

351

Conditions

Impaired Wound Healing Postoperative Wound Infection-deep

Interventions

Dry Sterile DressingOTHER

Described in Arm Description.

Metallic Silver DressingOTHER

Described in Arm Description.

Ionic Silver DressingOTHER

Described in Arm Description.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients seen in the pre-surgical testing area prior to admission for surgery * Having surgery at the study setting * English-speaking * Able to understand and give consent * Had the approval of their cardiothoracic surgeon to participate * Had no known sensitivity to silver * Had no known sensitivity to alginates Exclusion Criteria: * Known sensitivity to silver * Known sensitivity to alginates

Locations (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Wound Healing

The primary outcome measure in this study was wound healing, defined as the degree of wound approximation, skin integrity, exudate, and presence/absence of necrotic tissue, assessed at postoperative day 5 or day of discharge. Wound approximation was assessed as total, partial (less than 2 centimeters of superficial separation), moderate (greater than 2 centimeters of superficial separation), or dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.

Time frame: 5 days postoperatively or day of discharge, whichever came first

Secondary Outcomes

Patient Comfort

The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.

Time frame: 5 days postoperatively or day of hospital discharge, whichever came first

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.